Home › NDC Lookup › Ingredients › Fluticasone Propionate › 80159-0201-01
👃no package photo
in the FDA label

Picnic Allergy Symptom Reliever Nasal Fluticasone propionate 50 ug Spray, Metered

by 30M One, Inc. · 1 BOTTLE in 1 CARTON (80159-201-01) / 120 SPRAY, METERED in 1 BOTTLE
NDC 80159-0201-01
🏷️ FDA NDC (as labeled) 80159-201-01 billing pads the product segment with a zero
This package
Contains120 spray, metered in 1 bottle Pack sizes2 compare ↓
Also comes in: 3 bottles 80159-0201-03
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jan 19, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Fluticasone Propionate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 14, 2024 — CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex (Golden State Medical Supply Inc.) · FDA recall D-0349-2024
Class II · Feb 9, 2024 — CGMP Deviations: potential presence of Burkholderia cepacia complex (Apotex Corp.) · FDA recall D-0326-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Oct 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 80159-201-01
Product NDC 80159-201
11-digit billing NDC 80159020101
NCPDP billing unit ML — per mL (volume)
Application # ANDA207957
Established class (EPC) Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Oct 2024)
Route NASAL
Dosage form SPRAY, METERED
Substance FLUTICASONE PROPIONATE
Why two NDCs? The FDA registers this code as 80159-201-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 80159-0201-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

Labeler30M One, Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA207957 (ANDA)
Labeler code80159
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Nonprescription (over the counter) fluticasone nasal spray is used to relieve symptoms of rhinitis such as sneezing and a runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Prescription fluticasone nasal spray is used to relieve symptoms of nonallergic rhinitis such as sneezing and runny or stuffy nose which are not caused by allergies. Prescription fluticasone nasal spray (Xhance) is used to treat chronic rhinosinusitis with or without nasal polyps (ongoing runny nose, sinus swelling and/or nasal co...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
📖 Read our full Fluticasone guide →
8
Nutrient depletion considerations

Fluticasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Fluticasone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 3 bottles
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluticasone Propionate 50 ug 00054-3270-99 Hikma 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate 50 ug 60505-0829-01 Apotex 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate spray, metered 50 ug 62135-0810-61 Chartwell 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate 50 ug 71085-0090-16 IPG 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate 50 ug 72888-0141-35 Advagen 1 bottle $0.448 AB Availability likely —
good neighbor pharmacy fluticasone propionate 50 ug 46122-0684-29 Amerisource 1 bottle $0.692 — Availability likely —
Fluticasone Propionate 50 ug 83324-0294-01 Chain 1 bottle $0.692 — Availability likely —
leader fluticasone propionate 50 ug 70000-0703-01 Cardinal 1 bottle $0.813 — Availability likely —
Foster and Thrive Allergy Relief 50 ug 70677-1021-01 Strategic 1 bottle $0.813 — Availability likely —
Good Sense 24 hour allergy nasal 50 ug 00113-0028-01 L. 1 bottle $0.845 — Discontinued —
Rugby Fluticasone Propionate Nasal 50 ug 00536-1183-65 Rugby 1 bottle $0.897 — Availability likely —
Fluticasone Propionate 50 ug 60505-6205-03 Apotex 1 bottle $0.897 — Availability likely —
Good Sense 24 hour allergy nasal 50 ug 00113-0285-08 L. 1 bottle — — FDA listed —
Flonase Allergy Relief 50 ug 00135-0576-01 Haleon 1 bottle — — FDA listed —
Childrens Flonase Allergy Relief 50 ug 00135-0582-04 Haleon 1 bottle — — FDA listed —
24 Hour Allergy Nasal 50 ug 00363-0024-01 Walgreen 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 00363-0652-01 Walgreens 1 bottle — — FDA listed —
Childrens Allergy Relief 50 ug 00363-4023-08 Walgreen 1 bottle — — FDA listed —
Up and Up Allergy Relief Nasal 50 ug 11673-0103-04 Target 3 bottles — — Discontinued —
Fluticasone Propionate 50 ug 11673-0262-01 Target 1 bottle — — Discontinued —
allergy nasal 50 ug 11822-0901-03 Rite 1 bottle — — FDA listed —
Signature Care Allergy Relief 50 ug 21130-0089-08 Safeway 1 bottle — — Discontinued —
signature care childrens allergy relief 50 ug 21130-0122-08 Safeway 1 bottle — — Discontinued —
childrens allergy relief 50 ug 21130-0607-08 Safeway 1 bottle — — FDA listed —
allergy relief 50 ug 21130-0863-08 Safeway 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 30142-0258-01 The 1 bottle — — FDA listed —
TopCare Childrens Allergy Relief Nasal 24 Hour 50 ug 36800-0128-02 Topco 1 bottle — — Discontinued —
topcare fluticasone propionate nasal 50 ug 36800-0222-01 Topco 1 bottle — — FDA listed —
Nasopro 24 50 ug 37808-0205-02 H 1 bottle — — Discontinued —
Childrens Nasopro 50 ug 37808-0340-08 H 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 37835-0997-31 Bi-Mart 1 bottle — — FDA listed —
Equaline Fluticasone Propionate 50 ug 41163-0023-01 United 1 bottle — — Discontinued —
Allergy Relief 50 ug 41250-0634-08 Meijer 1 bottle — — FDA listed —
careone childrens allergy relief 50 ug 41520-0553-02 American 1 bottle — — FDA listed —
CareOne Allergy Relief 50 ug 41520-0703-01 American 1 bottle — — FDA listed —
allergy relief nasal 50 ug 42507-0710-08 HyVee 1 bottle — — FDA listed —
365 Whole Foods Market Fluticasone Propionate 50 ug 42681-0058-01 Whole 1 bottle — — FDA listed —
equate allergy relief 50 ug 49035-0200-01 Wal-Mart 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 49035-0362-01 Walmart 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 50090-0968-00 A-S 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 50090-2880-00 A-S 1 bottle — AB FDA listed —
Rugby Fluticasone Propionate Nasal 50 ug 50090-6823-00 A-S 1 bottle — — FDA listed —
allergy nasal 50 ug 51316-0181-08 CVS 1 bottle — — FDA listed —
Childrens Allergy 50 ug 51316-0197-08 CVS 1 bottle — — FDA listed —
Allergy Relief 50 ug 51316-0497-08 CVS 1 bottle — — FDA listed —
childrens allergy relief 50 ug 51316-0818-08 CVS 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 51407-0871-12 Golden 1 bottle — AB FDA listed —
Allergy Relief 50 ug 53943-0006-01 Discount 1 bottle — — FDA listed —
exchange select allergy relief 50 ug 55301-0506-01 Army 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 55319-0058-01 Family 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 55681-0389-14 TWIN 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 55700-0714-16 Quality 1 bottle — AB FDA listed —
DG Health childrens allergy relief nasal 50 ug 55910-0607-02 Dolgencorp 1 bottle — — FDA listed —
DG Health Allergy Relief Nasal 50 ug 55910-0773-01 Dolgencorp 1 bottle — — FDA listed —
allergy relief nasal 50 ug 56062-0107-08 Publix 1 bottle — — FDA listed —
Fluticare 50 ug 57483-0180-11 INNOVUS 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 58602-0017-42 Aurohealth 1 bottle — — FDA listed —
Childrens Fluticasone Propionate 50 ug 58602-0018-04 Aurohealth 3 bottles — — FDA listed —
Allergy Relief 50 ug 59726-0203-38 P 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 60429-0195-15 Golden 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 60505-0955-01 Apotex 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 63187-0638-16 Proficient 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 63187-0806-16 Proficient 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 63654-0380-01 Selder, 1 bottle — — FDA listed —
Kirkland Signature Aller Flo 50 ug 63981-0001-01 Costco 120 sprays — — FDA listed —
Welby Fluticasone 50 ug 64024-0007-02 Aldi 1 bottle — — FDA listed —
Allergy Relief 50 ug 64525-6560-02 Quality 1 bottle — — FDA listed —
Good Sense 24 hour allergy nasal 50 ug 67296-1463-01 RedPharm 11 sprays — — FDA listed —
Fluticasone 50 ug 68071-1638-05 NuCare 16 sprays — AB FDA listed —
Fluticasone Propionate 50 ug 68071-3949-05 NuCare 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68071-4868-05 NuCare 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68196-0210-01 Sam's 6 bottles — — Discontinued —
Fluticasone Propionate 50 ug 68196-0503-01 Sam's 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 68788-4120-01 Preferred 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68788-8446-01 Preferred 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68788-9678-01 Preferred 1 bottle — AB FDA listed —
Allergy Relief Nasal 50 ug 68998-0452-01 Marc 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 68998-0600-01 Marc 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 69168-0014-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 69168-0380-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 69168-0448-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 69168-0452-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate Nasal 50 ug 69842-0900-01 CVS 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 70518-0880-00 REMEDYREPACK 1 spray — AB FDA listed —
Fluticasone Propionate 50 ug 70518-1655-00 REMEDYREPACK 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 72189-0004-01 Direct_RX 1 spray — AB FDA listed —
basic care allergy relief nasal 50 ug 72288-0119-04 Amazon.com 3 bottles — — Discontinued —
basic care childrens allergy relief nasal 50 ug 72288-0333-08 Amazon.com 1 bottle — — FDA listed —
Fluticasone Propionate ALLERGY RELIEF 50 ug 72657-0159-12 GLENMARK 1 bottle — — FDA listed —
Mucinex Nasal Congestion and Allergy Relief 50 ug 72854-0227-60 Reckitt 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 72888-0248-01 Advagen 1 bottle — — FDA listed —
Topcare Allergy Relief Nasal 50 ug 76162-0121-08 Topco 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug/.1g 76420-0106-16 Asclemed 16 g — — FDA listed —
Fluticasone Propionate 50 ug 76420-0329-50 Asclemed 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 76420-0903-01 Asclemed 1 bottle — AB FDA listed —
Equate Allergy Relief 50 ug 79903-0071-10 WALMART 2 bottles — — FDA listed —
Equate Childrens Allergy Relief 50 ug 79903-0295-72 WALMART 1 bottle — — FDA listed —
Rugby Fluticasone Propionate Nasal 50 ug 85766-0161-12 Sportpharm 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 85828-0448-01 Grocery 1 bottle — — FDA listed —
Rugby Fluticasone Propionate Nasal 50 ug 87063-0114-12 ASCLEMED 1 bottle — — FDA listed —
Picnic Allergy Symptom Reliever Nasal 50 ugthis 80159-0201-01 30M 1 bottle — — Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Fluticasone Propionate (matched by generic name) — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Fluticasone Propionate. CMS lists 5 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$55.37M
Claims incl. refills
3.4M
Beneficiaries
2.6M
Spend / beneficiary
$21.45
Spend / claim
$16.15
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80159-0201-01 You're viewing this 1 BOTTLE in 1 CARTON (80159-201-01) / 120 SPRAY, METERED in 1 BOTTLE 2021-01-19 Discontinued by firm
80159-0201-03 3 BOTTLE in 1 CARTON (80159-201-03) / 120 SPRAY, METERED in 1 BOTTLE 2021-12-09 Discontinued by firm

Pack size FAQ

What quantity is in NDC 80159-0201-01?
NDC 80159-0201-01 is listed by the FDA — 1 bottle in 1 carton / 120 spray, metered in 1 bottle.
What NDC number is used to bill for this package of Picnic Allergy Symptom Reliever Nasal Fluticasone propionate 50 ug Spray, Metered?
Bill NDC 80159-0201-01 — the 11-digit billing format is 80159020101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC The FDA label for this product carries no photos.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 80159-201-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 80159-0201-01, written without dashes as 80159020101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 80159-0201-01, the first segment (80159) is the labeler code FDA assigned to 30M One, Inc.; the middle segment (0201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 3 bottles (80159-0201-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
30M One, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
← 80151-0002-02 · FLEMING 80216-0111-02 · Sano →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.